(87 days)
The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter.
The electrodes are intended for short-term use (< 8 hours) and must be used before the expiration date listed on the packaging. These electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patient skin.
The SVL-9630 electrodes consists of a pair of non sterile, hydrogel polymeric selfadhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.
The provided document is a 510(k) summary for the Survivalink SVL-9630 Disposable Polymer (Hydrogel) Multifunctional Electrode. The document states that the device is substantially equivalent to predicate devices and meets AAMI DF-39 performance standards. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information for AI/algorithm performance studies.
This document describes a medical device, which is an electrode for defibrillators and pacemakers, not an AI or algorithm-based diagnostic tool. Therefore, many of the requested fields (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to the information provided.
Based on the provided text, here's what can be extracted:
1. A table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (from AAMI DF-39) | Reported Device Performance |
|---|---|
| Specifications for single use hydrogel electrodes (AAMI DF-39) | Met all specifications. |
| Survivalink's internal specifications | Met all specifications. |
| Functioned as intended | Functioned as intended. |
Note: The specific parameters of AAMI DF-39 that were tested (e.g., impedance, adhesion, current distribution) are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. This is a physical medical device (electrode), not an algorithm. The testing would involve engineering and biocompatibility evaluations, not data sets from patients in the context of AI performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of expert consensus, is for diagnostic algorithms.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document pertains to a physical electrode, not an AI system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of diagnostic algorithms. For an electrode, ground truth would relate to its physical and electrical performance against established standards.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
{0}------------------------------------------------
SurVivaLink
Amendment 1
P.05/06
DEC I 0 1999
510(k) Summary
ADMINSTRATIVE INFORMATION H-1.
H-1.1 Name and address
Survivalink Corporation Submitted by: 5430 Feltl Road Minneapolis, MN 55343
| Contact Person: | Sew-Wah Tay, Ph.D. |
|---|---|
| Telephone No .: | 612-939-2942 |
| Facsimile No .: | 612-939-4191 |
| Email address: | stay@survivalink.com |
Date Prepared: September 8, 1999
H-1.2 Device Name
| Common or Usual Name: | Disposable Polymer (Hydrogel) Multifunctional Electrode |
|---|---|
| Device Name: | SVL-9630 |
| Trade Name: | SVL-9630 |
Classification Name H-1.3
Disposable Single Use Accessory (Electrode) to: a) Semi-automatic low energy DC defibrillator 21CFR 870.5300; Class II b) Cardiac Monitor (Cardiotachometer and Rate Alarm) 21CFR $870.2300; Class II
H-1.4 Applicant
| Applicant's Name: | Survivalink, Corporation5430 Feltl RoadMinneapolis, MN 55343 |
|---|---|
| ------------------- | ---------------------------------------------------------------------- |
H-2. PREDICATE DEVICE
H-3. INDICATION FOR USE
The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter.
{1}------------------------------------------------
510(k) K993072
The electrodes are intended for short-term use (<8 hours) and must be used before the expiration date listed on the packaging. These electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patient skin.
DEVICE DESCRIPTION H-4
The SVL-9630 electrodes consists of a pair of non sterile, hydrogel polymeric selfadhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.
H-5 SUBSTANTIAL EQUIVALENCE
The Company's SVL-9630 electrodes covered by this submission are substantially equivalent to other legally marketed electrodes for semi-automatic low power DC defibrillators. Specifically, the SVL-9130 electrode is substantially equivalent to SVL-9130 electrodes (K971146) and Katecho's D-Defib/Pace electrodes (K 981737).
PERFORMANCE DATA H-6.
The SVL-9630 electrodes meet all the specifications for single use hydrogel electrodes of the AAMI DF-39 specifications and Survivalink's internal specifications. In all instances, the SVL-9630 electrodes functioned as intended.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three human profiles facing right, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1999
Sew-Wah Tay, Ph.D. Survivalink Corporation 5420 Feltl Road Minneapolis, MN 55343
Re: K993072 Survivalink 9630 Defibrillation Electrode Regulatory Class: III (three) Product Code: 74 MLN September 13, 1999 Dated: Received: September 14, 1999
Dear Dr. Tay:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - Sew-Wah Tay, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
,
Carl C. Casey
Celia M. Witten, Ph. D , M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) K993072
Amendment 1
Indication for Use
510(k) Number: K993072
Device Name: Survivalink Multifunctional Electrode (SVL-9630).
INDICATION FOR USE 1.
The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter.
The electrodes are intended for short-term use (< 8 hours) and must be used before the expiration date listed on the packaging. These electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patient skin.
Daerle C. Cruz
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number
PRESCRIPTION USE
(PER 21 CFR 801.109)
A. Carey
12/8/95
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.